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AbbVie Files Venetoclax sNDA for Use in AML

AbbVie has submitted a supplemental NDA for venetoclax in combination with a hypomethylating agent or in combination with low-dose cytarabine for treating newly diagnosed patients with acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy. The submission is based on investigational data from two studies: M14-358, a Phase 1b trial evaluating venetoclax in combination with azacitidine or decitabine, and M14-387, a Phase 1/2 trial of venetoclax in combination with low-dose cytarabine. AML, primarily a disease of older patients, is the most common form of acute leukemia in adults, in which the bone marrow makes abnormal, immature types of white blood cells, red blood cells or platelets.

Venetoclax recently received expanded approval in the U.S. for use alone or in combination with rituximab for treating relapsed/refractory chronic lymphocytic leukemia small lymphocytic lymphoma patients, with or without 17p deletion, who have received at least one prior therapy.

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